Effect of Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Hemodialysis

NCT ID: NCT07181746

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-05-03

Brief Summary

The study aimed to evaluate the effect of Pilates exercises on restless leg syndrome, functional capacity and physical self-perception among older adult undergoing hemodialysis. participants are 60 elderly patients both male and female who undergoing maintenance hemodialysis.

Detailed Description

The research hypothesis include : H1: Older Adult Undergoing Hemodialysis who will practice Pilates exercises will have less severity of the Restless Leg Syndrome, and high Functional Capacity and Physical Self-Perception than those who will not practice.

Participants were divided into two groups (study and control). Both groups were asked to fill out all questionnaires before and after the study using the same tools. In the control group, older adult receives routine care, which was provided by the hospital as examination, routine medication . Participants were asked to answer a post-test using the same pre-test questionnaires. And the study group were divided into small training groups with 3-5 older adult for each group.

Conditions

Hemodialysis; Functional Capacities; Excercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention group

Pilates Exercises

Group Type: ACTIVE_COMPARATOR

leg exercises

Intervention Type: PROCEDURE

The patient in study group will offer 72 planned sessions along 16-week period, each session consisted of 5 minutes walking as a warm-up, followed by 30 to 45 minutes of resistance exercises tolerated by the patient, time maintained until the end of the intervention. Each participant will receive about two to three, personal training session regarding the technique of resistance training until they are perfect in performing the exercises. Participants will receive a booklet with instructions on the Pilates training illustrated by colored pictures. The sessions during the staying the patient's in the hospital will be supervised by the researchers

Interventions

leg exercises

The patient in study group will offer 72 planned sessions along 16-week period, each session consisted of 5 minutes walking as a warm-up, followed by 30 to 45 minutes of resistance exercises tolerated by the patient, time maintained until the end of the intervention. Each participant will receive about two to three, personal training session regarding the technique of resistance training until they are perfect in performing the exercises. Participants will receive a booklet with instructions on the Pilates training illustrated by colored pictures. The sessions during the staying the patient's in the hospital will be supervised by the researchers

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Age of ≥ 65 years old,

• A History of hemodialysis treatment two to three times per week for at least six months,
• Interest in participation,
• Being able to move independently and with a physical condition certified by a physician to play the sport, with no myocardial infarction or surgery in the past six months of the study.

Exclusion Criteria

• Three or more absences in exercise sessions;
• Being a habitual Pilates practitioner;
• Detection of reduced exercise tolerance, including tachycardia, shortness of breath, and feeling too tired or weak;
• Peritoneal dialysis during the study; and other concurrent clinical conditions, such as cardio-respiratory problems reported by physician and/or patients

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norther Private Collage of Nursing

OTHER

Sponsor Role: lead

Responsible Party

Amal Hashem

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Amal Mohamed, phd

Role: CONTACT

amalm53@yahoo.com

0568637931

Amal Hashem Associate, phd

Role: CONTACT

amalm53@yahoo.com

0568637931

Other Identifiers

amalhasem@nec.edu.sa

Identifier Type: -

Identifier Source: org_study_id